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510(k) K953506

WESTMED RESPIRATORY LUER ADAPTOR by Westmed Intl. — Product Code BXY

K953506 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "WESTMED RESPIRATORY LUER ADAPTOR". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code BXY (Flowmeter, Calibration, Gas), a Class I device regulated under 21 CFR 868.2350. Westmed Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
July 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Calibration, Gas
Device Class
Class I
Regulation Number
868.2350
Review Panel
AN
Submission Type

Other clearances by Westmed Intl.

  • K955047 — WESTMED CIRCULARIE PEP DEVICES (March 27, 1996)
  • K954271 — WESTMED CONDESATE COLLECTION TRAP (December 28, 1995)
  • K952616 — MICROTIME (September 27, 1995)
  • K953687 — WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER (September 18, 1995)
  • K951484 — WESTMED BACTERIAL/VIRAL FILTER (April 24, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K924944 — INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA (July 2, 1993)
  • K925173 — BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT (January 15, 1993)

Other clearances for product code BXY

  • K902916 — PRECISION MEDICAL NEB BLOCK (July 23, 1990)
  • K902917 — PRECISION MEDICAL ELIMINATOR (July 23, 1990)
  • K863510 — OXY-OFF(TM) (October 22, 1986)
  • K860516 — LSP MINILATOR (February 21, 1986)
  • K851460 — NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA (May 10, 1985)
  • K781523 — PFT GASES (December 1, 1978)

FDA data resources